Technical Lead (API)
Life Science Recruitment are currently sourcing an API Technical Shift Leader to lead, coach and drive results with a high performing API manufacturing team.
Roles & Responsibilities
• Supervision and execution of pharmaceutical processing activities in the API building and support locations, to meet operating objectives. Daily reporting on the status of all operations and support activities.
• Team leadership, motivation and direction to maximise the effectiveness of the manufacturing team. The Technical Shift Leader must clearly communicate task details and goals to team members.
• Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.
• Act as key point of technical contact for API Business Unit. Shift technicians report directly to this role.
• Communicate the departmental goals, to provide cost effective products as part of the Class A supply chain system.
• Liaise with Supply chain & program management teams to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing
• Resolves operations/project issues by working with team members, project customers, and others as appropriate.
• Responsible for driving operations excellences and Key operations targets including OEE where applicable.
• Ensure the execution of pharmaceutical processing activities in the API building and support locations, to meet clearly stated operating objectives.
• Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.
• Drive safety improvements and initiatives across the operation.
• Ensure successful review, amendment and implementation of changes to SOPs and managing CAPA’s.
• Promote a culture of perfect performance and Enhanced Right first time within their team.
• Liaise with the relevant departments & customers in the introduction and execution of NPIs Projects.
• Adheres to and supports all EHS & E standards, procedures and policies.
• Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.
• Assist and cooperate with HR in the management of employee relations issues.
• Interact with internal and external customers, by regularly meeting with, responding to requests and explaining procedures.
• Maintains personnel records on KRONOS and makes modifications in the database to reflect actual changes.
• Assist in the identification, implementation and execution of key API and Site Strategies.
• Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.
Skills & Qualifications
• Degree, master’s or PhD in Life Sciences or a Process/Chemical Engineering discipline.
• A minimum of 5 years’ experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
• Background as a technical leader in either a process engineering, formulations and technical transfers capacity.
• Experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead & project manage these activities.
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements.
• Previous exposure to supply chain & schedule delivery in a manufacturing environment.
• A minimum of 1-year previous experience of supervising a team environment with active participation in proactive improvement programs.
If you would like further Information you can contact the recruiter directly:
Simon Gillivan | Tel: +353 (0) 1 507 9258
PLEASE APPLY DIRECTLY BY CLICKING HERE
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